Percentage of Patients Experiencing Adverse Events
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 73.1 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Canada, Mexico, Romania, South Africa
1 trial · 1 completed · 1 with posted results
Safety of Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus Treated With Thiazolidinedione Alone or Thiazolidinedione in Combination With Metformin
NCT00753896Oct 2008 to Nov 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will examine the safety of exenatide once weekly (2.0 mg) in approximately 134 patients receiving treatment with thiazolidinedione alone or thiazolidinedione in combination with metformin. Patients are expected to be treated with exenatide once weekly for at least 52 weeks.
Experimental
1
Outcomes the sponsor listed as primary.
Percentage of Patients Experiencing Adverse Events
Time frame · Baseline to Week 52
Percentage of patients experiencing treatment-emergent adverse events over 52 weeks
Assessment of Event Rate of Treatment-Emergent Hypoglycemic Events
Time frame · Baseline to Week 52
Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Change in HbA1c From Baseline to Week 52
Time frame · Baseline, Week 52
Change in HbA1c from baseline to endpoint
Percentage of Patients Achieving HbA1c <=7% at Week 52
Time frame · Baseline, Week 52
Percentage of patients achieving HbA1c \<=7% at endpoint (for patients with HbA1c \>7% at baseline)
Percentage of Patients Achieving HbA1c <=6.5% at Week 52
Time frame · Baseline, Week 52
Percentage of patients achieving HbA1c \<=6.5% at endpoint (for patients with HbA1c \>6.5% at baseline)
Change in Fasting Serum Glucose From Baseline to Week 52
Time frame · Baseline, Week 52
Change in fasting serum glucose from baseline to endpoint
Change in Body Weight From Baseline to Week 52
Time frame · Baseline, Week 52
Change in body weight from baseline to endpoint
Change in Total Cholesterol From Baseline to Week 52
Time frame · Baseline, Week 52
Change in Total Cholesterol from baseline to endpoint
Change in High-density Lipoprotein (HDL) From Baseline to Week 52
Time frame · Baseline, Week 52
Change in HDL from baseline to endpoint
Change in Triglycerides From Baseline to Week 52
Time frame · Baseline, Week 52
Change in Triglycerides from baseline to endpoint
Change in Blood Pressure From Baseline to Week 52
Time frame · Baseline, Week 52
Change in Systolic and Diastolic Blood Pressure from baseline to endpoint
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 73.1 |
| Group | Value (events per subject-year) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.00 | 0.000 |
| Group | Value (percentage of total hemoglobin) | Spread |
|---|---|---|
| Exenatide Once Weekly | -0.78 | 0.07 |
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 68.8 |
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 54.2 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.59 | 0.21 |
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.50 | 0.45 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -0.18 | 0.08 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Once WeeklySubcutaneous injection, 2.0mcg, once weekly. | – | 9 / 134 | 67 / 134 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Clinical trial · 2012
Norwood et al. 2012Clinical therapeuticscited by 21
PMID 23031623DOI 10.1016/j.clinthera.2012.09.007PUB-23031623
Who could join, as posted.
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